Methods and compositions for treating benign gynecological disorders

• US 6,960,337 B2
• Filed: 11/15/2002
• Issued: 11/01/2005
• Est. Priority Date: 08/02/2002
• Status: Expired due to Fees

• Current Assignee: Balance Pharmaceuticals, Inc.
• Original Assignee: Balance Pharmaceuticals, Inc.
• Inventors: Daniels, Anne-Marie, Daniels, John R., Spicer, Darcy V., Pike, Malcolm C.
• Primary Examiner(s): Kunz, Gary
• Assistant Examiner(s): Haghighatian, Mina
• Application Number:
  US10/298,851
• Publication Number:
  US 20040023867A1
• Time in Patent Office: 1,082 Days
• Field of Search: 424/45, 424/434, 424/426, 424/239, 514/2, 514/841, 514/843, 514/874, 514/58
• US Class Current: 424/45
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 38/24 Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]

Abstract

An improvement in a method of treating benign gynecological disorders is described. In the method, treatment of a benign gynecological disorder with a composition comprised of a gonadotropin releasing hormone (GnRH) compound and an estrogenic compound, and optionally, an androgenic compound, is extended to premenopausal women who are not receiving an exogenously supplied progestin on a regular or periodic basis. Treatment in accord with the invention does not increase significantly the risk of endometrial hyperplasia. The method is also suitable for contraception.

Claims

1. A method of treating a benign gynecological disorder in a patient population composed of premenopausal women, comprising, administering a gonadotropin releasing hormone (GnRH) compound, in an amount effective to suppress ovarian estrogen and progesterone production, and an estrogenic compound, in an amount effective to prevent signs and symptoms of estrogen deficiency, along with, optionally, an androgen, in an amount effective to prevent signs and symotoms of androgen deficiency, for a time oeriod of more than about 4 months, with the proviso that women in the patient population do not receive an exogenously supplied progestin during said time period to prevent endometrial hyperplasia.

2. The method of claim 1, wherein the GnRH compound is a GnRH peptide agonist, and the compound is administered intranasally.

3. The method of claim 1, wherein the GnRH compound is selected from the group consisting of deslorelin, leuprolide, nafarelin, goserelin, decapeptyl, buserelin, histrelin, gonadorelin, abarelix, cetrorelix, azaline B, and degarelix, and analogs thereof.

4. The method of claim 3, wherein the GnRH compound is administered by an intranasal route, and the estrogenic compound is 17β

-estradiol administered by a transdermal route, at a daily dose between 0.025 and 0.1 mg.

5. The method of claim 4, which further includes co-administering testosterone transdermally, at a daily dose sufficient to increase serum testosterone to the premenopausal range of between 15 and 80 ng/dL.

6. The method of claim 3, wherein the GnRH compound and the estrogenic compound are co-administered intranasally, in an aerosol spray containing a daily spray volume between 30 and 200 μ

L, and between 0.15 and 0.6 mg of 17β

-estradiol.

7. The method of claim 6, which further includes co-administering testosterone intranasally in the aerosol spray at a daily dosage of between 0.15 and 1 mg testosterone.